Hospital to offer new treatment for hep C victims: Experimental drug could be available as early as September

Tuesday

Jul 17, 2012 at 3:15 AMJul 17, 2012 at 7:52 AM

By JIM HADDADINjhaddadin@fosters.com

DOVER — People who contracted hepatitis C while being treated at Exeter Hospital could soon be eligible to receive an experimental new treatment for the liver disease at no cost.

Massachusetts General Hospital is finalizing an agreement with a drug manufacturer that would allow patients to receive the new drug as part of a clinical trial, according to Dr. Raymond Chung, vice chief of the MGH gastrointestinal unit, and medical director of MGH's liver transplant program.

He declined to name the drug company involved in the trial, but he described the treatment as an antiviral medication administered as an oral treatment.

The treatment is now in the second phase of testing to gain approval from the Food and Drug Administration. So far, studies of people with chronic hepatitis C infections who took the drug have shown "substantial and sustained response rates that are tantamount to cure," Chung said.

The drugs are also promising in relation to Exeter Hospital because they produce more tolerable side effects than the standard care available now for hepatitis C, he said.

One of the most difficult things for people on hepatitis C therapy to deal with is the side effects caused by the interferon injections and ribavirin pills, according to information provided by the Department of Veterans Affairs. The drugs are used in combination as the standard treatment option for the virus.

Chung said the new oral treatment could be available as early as September for Exeter Hospital patients infected during the outbreak. He stressed that those who wish to take part in the clinical trial will need to hold off on beginning other treatments for hepatitis C until the trial begins, including drug cocktails that include interferon shots.

"We really wanted to find a way to make available a treatment that could spare them the adversity of dealing with the numerous side effects that interferon carries with it," he said.

So far, the drug manufacturer has only tested the drug in trials that involve people with long-standing hepatitis C infections.

The clinical trial involving Exeter Hospital patients will explore whether the efficacy of the drug is higher among people with fairly new infections.

Among people carrying the virus, the infection often goes undetected for years, though it can lead to serious liver damage.

Chung said the new trial for Exeter Hospital patients won't require any additional involvement from the FDA, since it will fall under the regulatory umbrella of a pre-existing trial agreement.

The program will last approximately 12 weeks.

Chung said MGH has hosted clinical trials of a variety of experimental hepatitis C drugs in the past, including the manufacturer currently in talks to take part in the clinical trial.

"In meeting with some of these patients, you know, I am struck by the real anguish of the experience for them," he said, "and ... the trauma of having experienced the event. I think the availability of a regimen that could reverse that state, that could undo what's been done, I think could go a long way toward restoring their overall physical and emotional health."

The number of people who were infected with hepatitis C while being treated at Exeter Hospital now stands at 30.

State health officials announced Thursday that four additional patients have tested positive for the liver disease, joining 26 others who were previously diagnosed.

One hospital employee is also carrying the virus, bringing the total number of related cases to 31.

The tally has increased steadily since the end of May, when Exeter Hospital administrators held a news conference to announce the discovery of the first four cases.

Since then, the state has launched a large-scale lab testing program to screen more than 1,000 former Exeter Hospital patients who were potentially exposed to the virus.

The Department of Health and Human Services has asked all patients treated in Exeter Hospital's cardiac catheterization laboratory and adjacent recovery room between Oct. 1, 2010 and May 25, 2012, to get tested for hepatitis C. The only known connection between the virus carriers is that they had contact with those areas of the hospital.

In June, state health officials announced they suspect the outbreak was caused by a hospital employee who stole and injected hospital drugs, then infected patients with contaminated needles or syringes.

Both the New Hampshire attorney general and the U.S. Attorney's Office have announced they are investigating the situation at the hospital to determine whether a criminal act occurred.